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Orphan Drugs: FDA September 2014 Approvals

October 1, 2014





The chart below identifies Orphan Drugs receiving FDA September 2014 approval as of 09/30/14 in ascending “Approval Date” order.

FDA September 2014 Orphan Products Receiving Approval

Generic Name/Approval Date  Sponsor Company Indication
1 Pembrolizumab (Keytruda)/ 09.04 Merck Unresectable/metastatic melanoma & disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
2 Adalimumab (Humira)/ 09.23 AbbVie Patients > 6 years of age with moderately to severely active Crohn’s disease who had an inadequate response to corticosteroids/ immunomodulators


Please Note: “First Pigment Analysis (5893349712)” by NASA ICE (First Pigment Analysis Uploaded by russavia) [CC-BY-2.0] | Wikimedia Commons.

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